NCT00676780

Brief Summary

The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2 prostate-cancer

Timeline
Completed

Started May 2004

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

August 8, 2012

Completed
Last Updated

August 8, 2012

Status Verified

June 1, 2012

Enrollment Period

4.6 years

First QC Date

May 9, 2008

Results QC Date

August 29, 2011

Last Update Submit

June 29, 2012

Conditions

Prostate Cancer

Keywords

EGCGpolyphenolsbiomarkersprostate specific antigen

Outcome Measures

Primary Outcomes (3)

  • Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer

    Change in serum prostate specific antigen (PSA) from baseline to post Polyphenol E treatment.

    Baseline and 6 weeks

  • Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer.

    Change in serum vascular endothelial growth factor (VEGF) from baseline to post Polyphenol E treatment.

    Baseline and 6 weeks.

  • Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer.

    Change in serum hepatocyte growth factor (HGF) from baseline to post Polyphenol E treatment.

    Baseline and 6 weeks

Study Arms (1)

ECGC Extract

EXPERIMENTAL

Single arm for a phase II study

Drug: Polyphenon E (EGCG)

Interventions

Polyphenon E (EGCG)DRUG

4 capsules daily with a meal for the duration of the study

Also known as: Polyphenon E
ECGC Extract

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recent biopsy positive for prostate cancer
  • scheduled for prostatectomy
  • must be able to swallow capsules
  • Palpable mass by digital rectal examination (DRE)
  • Ability to give informed consent and willingness to adhere to study protocol
  • Age ≥ 18 years and less than 75

You may not qualify if:

  • abnormal liver function
  • Prior hormonal or surgical therapy for prostate cancer
  • Liver or kidney problems that would interfere with metabolism of study drug
  • Any condition that would hamper informed consent or ability to comply with study protocol
  • Participation in another research study in the last three months
  • Known malignancy at any site other than prostate
  • Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LSU Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

Related Publications (1)

  • McLarty J, Bigelow RL, Smith M, Elmajian D, Ankem M, Cardelli JA. Tea polyphenols decrease serum levels of prostate-specific antigen, hepatocyte growth factor, and vascular endothelial growth factor in prostate cancer patients and inhibit production of hepatocyte growth factor and vascular endothelial growth factor in vitro. Cancer Prev Res (Phila). 2009 Jul;2(7):673-82. doi: 10.1158/1940-6207.CAPR-08-0167. Epub 2009 Jun 19.

    PMID: 19542190RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

polyphenon Eepigallocatechin gallate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Limitations and Caveats

Patient compliance was an issue.

Results Point of Contact

Title
Dr. Jerry W. McLarty, Ph.D.
Organization
LSUShreveport
jmclar@lsuhsc.edu
(318)813-1446

Study Officials

  • Jerry W McLarty, Ph.D.

    LSUHSC Shreveport

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 13, 2008

Study Start

May 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

August 8, 2012

Results First Posted

August 8, 2012

Record last verified: 2012-06

Locations

US(1)